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SWISS EXCHANGE
BioXell (SWX: BXLN) is a
biopharmaceutical company focused on the discovery and development of drugs
that exploit novel mechanisms of action to treat urological, inflammatory,
and related disorders with significant unmet medical needs and representing
large markets. The Company was founded in 2002 as a spin-out from Roche.
BioXell's strategic goal is to become a fully integrated pharmaceutical
company by maximizing the commercial potential of its product portfolio
and leveraging existing platforms into profitable partnerships. BioXell's
lead compound, Elocalcitol, derived from its proprietary VD3 (Vitamin D3)
technology platform, is in Phase II clinical trials for the treatment of
three distinct urological indications, Benign Prostatic Hyperplasia (BPH),
Overactive Bladder (OAB) and Non-bacterial Chronic Prostatitis (CP), and
is expected to enter a fourth Phase II clinical trial in Interstitial Cystitis
(IC) in the first half of 2007.
Since 2005 BioXell has a
TREM-1 fusion protein in development for the treatment of septic shock
in an exclusive partnership with Merck & Co., Inc. Furthermore, in
2006 BioXell in-licensed from Lay Line Genomics S.p.A. a novel anti-TrkA
monoclonal antibody, MNAC13, which represents a potential new approach
to the treatment of pain.
In June 2006, BioXell listed
its shares on the main segment of the SWX Swiss Exchange. BioXell currently
employs 58 people and has sites in Milan, Italy and Nutley, NJ, USA.
BioXell
reports half-year results 2007 - Progress on multiple fronts and strong
cash position
Milan,
Italy, 18 September 2007 - BioXell S.p.A. (SWX: BXLN) today reported its
2007 interim financial results. The Company made progress on several fronts.
In particular, BioXell advanced the clinical development of Elocalcitol
in two major urological indications and prepared for its clinical testing
in a third indication, while acquiring a new clinical stage compound. At
the same time, the Company maintains a strong financial position, with
more than € 63 million (CHF 104 million) in cash and cash equivalents
as of June 30, 2007. Net loss in the first six months of 2007 decreased
by 8% to € 6.4 million (according to US GAAP), compared to the first
half of 2006.
Major
developments 2007
"Last Patient-Last Visit" of Phase IIb trial of Elocalcitol in Benign Prostatic
Hyperplasia (BPH); results expected in the coming weeks
Start of a Phase IIb trial of Elocalcitol in Overactive Bladder (OAB)
Finalization of Phase IIa trial preparations of Elocalcitol in Male Infertility;
start of patient recruitment scheduled for Q4 2007
Acquisition of BXL746 from Roche, to be developed for Post-Surgical Adhesions
Regaining rights to TREM platform from Merck & Co, following termination
of the collaboration
Strengthening of management team with the addition of Niels Ackermann as
CFO, and Bertrand Lehuu as CBO
"BioXell's
strong financial position allows us to progress with the clinical development
of Elocalcitol and take our other clinical and preclinical assets forward,"
remarked Francesco Sinigaglia, CEO of BioXell. "It is our intention to
continue our in-licensing activities in order to further expand our pipeline
with innovative new compounds in our core therapeutic areas. We are committed
to pursuing our goal of becoming a fully integrated biopharmaceutical company."
BioXell
Reports 2006 Financial Results and Highlights for the year
Milan,
Italy, April 10, 2007 - BioXell S.p.A. (SWX: BXLN) today reported its financial
results for the full year 2006. The year was marked by a successful IPO
on the SWX Swiss Exchange in June, raising a total of € 40 million,
as well as a private financing round in March which raised an additional
€ 10.5 million. The Company ended the year 2006 with solid cash reserves
of € 71 million. Lead compound Elocalcitol reached Phase II milestones
in two key urological indications, with trials in a third indication scheduled
for 2007. A second clinical stage asset acquired from Roche, BXL 746, is
to be advanced into Phase II trials next year.
BioXell's
healthy financial position and a modest cash burn rate estimated at €
17 million for 2007 put the Company in a strong position to advance the
development of its clinical and preclinical phase assets while continuing
to pursue strategic partnerships, in-licensing and M&A activities.
Francesco
Sinigaglia, CEO of BioXell, commented, "2006 was an important year for
BioXell during which we made substantial progress in the development of
our pipeline. We reached key Phase II milestones for Elocalcitol, acquired
new clinical and preclinical assets, and obtained scientific results that
will lead to clinical trials in two new indications. With a successful
IPO and additional private financing, combined with a disciplined cash
burn rate, we ended the year on very solid financial footing. We are well
situated to drive forward our clinical programs, maximize the potential
of Elocalcitol and explore other opportunities to expand our pipeline."
BioXell
also announced that it has now been added to the SWX Swiss Exchange's SXI
LIFE SCIENCES and SXI Bio+Medtech indices, as of April 2, 2007. The full
2006 Annual Report is available and can be downloaded from the BioXell
website at www.bioxell.com. Hardcopies will go out by regular mail at the
end of next week.
R&D
Highlights
2006
was a significant year for BioXell as the company delivered progress on
multiple fronts, advanced its in-house programs, enriched its overall pipeline,
and increased shareholder value.
Elocacitol
reaches Phase II milestones in two key urological indications
The
clinical development of Elocalcitol in two major urological indications
is proceeding on schedule. The completion in May 2006 of the Phase IIa
trial of Elocalcitol in Overactive Bladder was a decisive milestone. The
results indicated that BioXell's lead compound may have comparable efficacy
to the "gold standard" anti-cholinergics in this indication, while avoiding
the side effects typically associated with this class of products. In the
first half of 2007 the Company will continue with a sophisticated "urodynamic"
Phase IIb study, with results due in 2008. Meanwhile, in December 2006
enrolment was completed in the Phase IIb trial of Elocalcitol in Benign
Prostatic Hyperplasia - the largest study ever conducted using MRI (Magnetic
Resonance Imaging) to measure prostate volume. Results will be available
in the second half of 2007. Success in either of these large indications
will confirm Elocalcitol's blockbuster potential.
Elocalcitol
to enter clinical trials for Male Infertility
A
trial of Elocalcitol in Chronic Prostatitis that ended in 2006 showed no
effect on the primary endpoint of pain reduction, but BioXell's scientists
observed a significant reduction in the semen levels of IL-8, a marker
of inflammation correlated with poor semen quality. A Phase II trial to
study the effect of Elocalcitol on semen parameters is scheduled for the
second half of 2007, potentially opening up a whole new therapeutic indication
for this remarkable compound.
BXL746
to enter clinical trials for Post-Surgical Adhesions
BioXell
acquired from Roche a second clinical stage asset, BXL746, which will be
advanced into Phase II trials next year for Post-Surgical Adhesions. Following
observations made while profiling BXL746 in a number of inflammatory conditions,
BioXell's scientists confirmed the compound's efficacy in reducing adhesion
formation in animals. Adhesions are an extremely frequent, unpleasant and
painful complication of surgery, and the medical need for avoiding them
is substantial.
Preclinical
pipeline
Two
other preclinical projects are moving along nicely. MNAC13, a fully humanized
antibody acquired from Lay Line Genomics in late 2005, represents an exciting
and innovative new approach to treating chronic and acute pain that may
avoid the drawbacks of current treatments. It is currently being further
characterized pharmacologically in-house in anticipation of its advancement
into clinical trials. Meanwhile, BioXell's collaboration on the TREM platform
with Merck & Co. is continuing on schedule, focusing on TREM-1 as a
means of preventing Sepsis - a massive infection that is the primary cause
of hospital deaths in emergency care units.
2006
Financial Highlights
€
40 million raised through a listing on the SWX Swiss Exchange in June
€
10.5 million in equity raised in a private financing round in March
Cash
reserves of € 71 million at year-end
Cash
burn of € 14. million for 2006 (vs € 7.5 million in 2005), reflecting
an increase in R&D activities to € 12.4 million (vs € 9.4
million in 2005)
Net
loss of € 13.8 million
Revenues
Total
revenues in 2006 amounted to € 2.5 million. BioXell currently derives
revenues from its collaboration with Merck & Co., which accounted for
€ 1.7 million in 2006, and from research grants.
Operating
expenses
Total
operating expenses in 2006 were € 17.9 million versus € 13.6
million in 2005, an increase of 32%. BioXell is channelling most of its
operating expenses (69%) into the development of its R&D pipeline.
Total
R&D expenses amounted to € 12.4 million versus € 9.4 million
in 2005, an increase of 32% largely due to the increase in clinical trial
costs for Elocalcitol - which completed enrolment of a 500+ patient trial
in Italy and Germany - as well as the costs associated with the acquisition
and development of MNAC13 and BXL746.
General
and Administrative expenses were € 5.5 million, representing 31% of
total operating expenses. These included mainly General Management, Business
Development, Information Technology and Communications.
Net
Loss
The
Company recorded a total net loss of € 13.8 million in 2006.
Balance
sheet
As
a result of the IPO, and considering the net loss for the year, total shareholders'
equity grew, as of December 31, 2006, to € 66.2 million versus €
33.9 million in the previous year, an increase of 95%. The Company ended
the fiscal year with € 71 million in cash and investment securities,
and maintained € 3.5 million in debt, a result of public financing
on favourable terms.
Financial
outlook
BioXell
expects a monthly cash burn rate of € 1.4 million in 2007 - in the
vicinity of € 17 million for the year - as it continues to expand
its R&D activities. In particular, 2007 will see the completion of
a Phase IIb trial of Elocalcitol in BPH, the start of a Phase IIb trial
of Elocalcitol in OAB, and the start of a Phase IIa trial of Elocalcitol
in Male Infertility. The Company is exercising strong financial discipline
as it makes maximum use of its resources to fund the advancement of its
pipeline.
BioXell
Announces New Members of Management Team
Milan,
Italy, March 26, 2007 - BioXell S.p.A. (SWX: BXLN) is pleased to announce
that Niels Ackermann will be joining the Company as Chief Financial Officer
as of April 16, 2007, and that Bertrand Lehuu has joined the Company as
Chief Business Officer since March 1, 2007. Alex Martin, who has held the
positions of CBO and, currently, CFO, will be returning to the United States
for personal reasons.
"We
are delighted to welcome these two outstanding professionals to our management
team. Their expertise will be instrumental in taking the Company forward
through new stages in its maturation in the coming years," commented Francesco
Sinigaglia, CEO of BioXell.
Mr.
Ackermann began his career in the investment banking division of Goldman
Sachs. He subsequently joined Cardion AG, a private German biotech company,
as CFO, and later became CFO of Wilex AG (DB: WL6), another German biotech
company. He joins BioXell from Morgan Stanley in London where he was a
Vice President in the firm's Global Capital Markets division, advising
and covering corporate clients in the German-speaking region on equity-related
financing structures, including IPOs and other equity capital measures.
"I
was extremely impressed with BioXell, including its people and its product
pipeline. Its recent status as a public company provides resources and
flexibility that I am confident I can help leverage," remarked Mr. Ackermann.
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